BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 24649185 · Received March 20, 2026

    Report

    Report Number
    3002808486-2026-00045
    Event Type
    Injury
    Date Received
    March 20, 2026
    Date of Event
    March 2, 2026
    Report Date
    March 20, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    00827002355811
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K233680. INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PATIENT UNDERWENT A FILTER IMPLANTATION THROUGH THE FEMORAL VEIN. AFTER REACHING THE DESIGNATED POSITION, THE FILTER WAS RETRACTED FOR RELEASE, BUT IT FAILED TO DEPLOY. THE SURGEON THEN ATTEMPTED TO WITHDRAW THE FILTER THROUGH THE ORIGINAL PATH, BUT IT COULD NOT BE REMOVED FROM THE PATIENT VIA THE ORIGINAL ROUTE. WHEN THE ENTIRE FILTER DELIVERY SYSTEM WAS WITHDRAWN BACK TO THE COMMON FEMORAL VEIN, THE INTERVENTIONAL PHYSICIAN INVITED A SURGEON TO PERFORM AN OPEN SURGICAL PROCEDURE TO REMOVE THE FILTER. PATIENT OUTCOME THE SURGEON PERFORMED A SURGICAL PROCEDURE TO REMOVE THE FILTER FROM THE PATIENT. UPON EXAMINATION, IT WAS FOUND THAT THE DELIVERY SYSTEM HAD BEEN BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714400 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G35581 E4757220 00827002355811

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention